Category: Generics Drug

New Delhi March 3, 2014:-
The Union Minister for Health and Family Welfare, Shri Ghulam Nabi Azad inaugurated the Convergence Block and Free Pharmacy Store at AIIMS, here today. 

Speaking at the occasion, Shri Ghulam Nabi Azad said that AIIMS New Delhi has about 9000-10,000 patients being treated at the OPD every day. Of these, many do not have the economic means to purchase medicines. The Generic Pharmacy Store will provide free medicines to such patients, he stated. It is estimated that about 4000 patients will benefit through this store per day. The expense on these free generic medicines will be about Rs. 1.2 cr every month, which will be borne by the Ministry of Health and Family Welfare, Shri Azad stated. 

The Health Minister said that the new Convergence Block will house the faculties for various departments such as Biology, Anatomy, Biochemistry, Physiology, Pharmacology and Pathology. It will also have teaching rooms, labs, research units along with a Knowledge Centre, he said. The Convergence Block has been built at the cost of Rs. 50.85 crore. It has ten floors and two basement areas. The total built area is of 18463 sq. Mts. The building design conforms to energy saving norms, the Minister added. 

Shri Azad also said that during the past five years, the Ministry has taken several decisions for enhancing the infrastructure of health care around the country and also to strengthen the human resources, at all levels, to match this. This has resulted in about 55% enhancement of MBBS seats and about 75% hike in MD seats. The Cabinet passed the proposal for creating 71 new cancer institutes last year, the Minister informed. In addition to this the Cancer Institute at Kolkata will be expanded with a new campus, he noted. 

Present at the occasion were Shri Lov Verma, Secretary, Ministry of Health and Family Welfare; Dr M C Mishra, Director, AIIMS; Shri C K Mishra, Addl. Secretary; and senior officers of the Ministry and faculty of AIIMS. 
Category: Generics Drug

Abu Hasem Khan Choudhury, India’s Minister of State for Health, would like more dialogue with the medical device industry before submitting a revised draft of the country’s Drugs & Cosmetics Bill.

Bangalore, February 24th , 2014: The Advanced Medical Technology Association (AdvaMed), along with other representatives of the global medical device industry, urged India’s Parliamentary Standing Committee on Health and Family Welfare to consider important modifications to the country’s Drugs & Cosmetics (Amendment) Bill 2013 to help ensure important benefits of the legislation, including more timely patient access to safe and effective medical treatments and cures for India’s patients, and greater access to needed capital for the country’s medical technology entrepreneurs and innovators.


The Committee’s recommendations, which were tabled in Parliament in December 2013, are currently being examined by the Ministry of Health and Family Welfare. On Feb. 9, Abu Hasem Khan Choudhury, Minister of State for Health and Family Welfare, emphasised the need to ensure that there is sufficient dialogue with stakeholders before submission of the revised bill. AdvaMed welcomes the Ministry’s resolve on this issue.


Referring to the concerns of the medical device industry, Choudhury said, “Medical devices and drugs are very different and we want to ensure that the distinction in their regulation is taken to the last mile.” He also added, “For the bill to have maximum impact, it is important for us to consider the views of other ministries, the industry and the civil society. We do not wish to hastily push forward a draft Bill without listening to the views of all stakeholders.” The minister stated that, once finalised, the Bill would ensure the highest standards of safety and efficacy. 


The medical device industry welcomes the ministry’s recognition of the critical need to differentiate medical devices from pharmaceutical products in the regulatory structure, and as a vital element of the Indian health care delivery system,” said Ralph Ives, Executive Vice President, Global Strategy and Analysis at AdvaMed. “We believe the revised Bill will improve industry’s ability to serve India’s growing health care needs in a safe, effective and timely manner. We commend and appreciate the government’s willingness to consult with all stakeholders on this very important legislation,” Ives said.


The Drugs and Cosmetics (Amendment) Bill 2013 proposes changes in the regulation of the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices, including measures to ensure product safety, efficacy and quality in clinical trials. Introduced in the Rajya Sabha in August last year, the Bill was later referred to the Standing Committee. The Bill is significant because it recognises medical devices as distinct from pharmaceuticals for the first time and brings needed clarity to device regulation. Consideration of concerns from all stakeholders will help address India’s health care challenges while ensuring maximum benefit for patients and the healthcare system.

Category: Generics Drug

New Delhi February 22, 2014:- Under the Drugs and Cosmetics Act, 1940 provisions related to manufacture and sale of drugs are administered by the State Drugs Control Authorities appointed by the State Governments. The information in respect of licenses issued by the State Licensing Authorities in each year is not maintained centrally. 

Local chemist authorized by Central Government Health Scheme supply the same drugs which are indented by the Wellness Centres. A certain discount is also given by them on the MRP in consonance with the Memorandum of Agreement (MoA) signed by them. Penalties can be imposed on the Authorised Local Chemist for substituting the indented medicines. 

This was stated by Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha today. 
Category: Generics Drug

New Delhi February 22, 2014:- Drugs, irrespective of their patent status, imported into the country are regulated by the office of Drug Controller General (India) under the provisions of the Drugs and Cosmetics Act, 1940 the Drugs and Cosmetics Rules, 1945 made thereunder, through the system of registration and import licenses. The criteria and procedure for grant of registration certificate of imported drugs and approval for marketing of new drugs have been prescribed under the Drugs and Cosmetics Rules, 1945.  


For the purpose of grant of Registration Certificates, the manufacturer abroad or his agent in India is required to make application to the office of Drug Controller General (India) in Form-40 along with specified fees, Power of Attorney in favour of the agent in India and the information and undertakings as specified in Schedule D(I) and D(II) of the said Rules duly signed by or on behalf of the manufacturer. Thereafter, the importer is required to obtain the import licence from the said authority for the import of the drugs registered for import.


For the purpose of import of newly introduced drugs i.e., new drugs, prior permission is required to be obtained from the office of the Drug Controller General (India) for marketing the drug in the country. The applicant is required to submit application in form-44 along with specified fees and technical data in respect of safety and efficacy of the drug for grant of permission to import the new drug into the country. The applicant is then required to get the drug registered for import in to the country.


The Central Drugs Standard Control Organisation (CDSCO) has detected the following cases of import of drugs from unregistered sources from China, which were handed over to CBI for investigations:


1.      M/s. Envee Drugs Pvt. Ltd, Gujarat.

2.      M/s. J B. Khokhani & Co, Mumbai.

3.      M/s. Sheetal Pharmaceutical, Mumbai

4.      M/s. Kawarlal& Co, and Kawarlal & Sons, Chennai

5.      M/s. Adcock Ingrahm, Bangalore

6.      M/s. Kanwarlal & Co, Chennai

7.      General Import Company (I) Pvt. Ltd., Mumbai.

8.      M/s Antonie & Becourel Organic Co., Chennai


Further, Good Manufacturing Practices (GMP) Certificates furnished by the following manufacturers of China were not found to be genuine, whose Registration Certificates and Import Licenses were then cancelled:

1.   M/s. Taizhou Waigaoqiao Liantong Pharmaceutical Co. Ltd., China

2.   M/s. Zhejiang Materials Industry Chemical Group Co. Ltd., China.

3.   M/s. Changshu Nanhu Industrial Chemical Factory , China.

4.   M/s. Jintan Zhongxing Pharmaceutical & Medical Co. Ltd., China.

5.   M/s. Suzhou Ausun Chemical Co. Ltd., China.

6.   M/s. Xianju Hongyan Pharmaceutical Chemicals Co. Ltd., China.

7.   M/s. Yanshi Shuda Medicine & Chemical Co. Ltd., China.

8.   M/s. Changzhou Kangrui Chemical Co. Ltd., Ch   ina.

9.   M/s. Ningbo Double Sun Pharmaceutical Co. Ltd., China.

10. M/s. Chongquing Chunrui Medicine Chemical Co. Ltd., China

11.  M/s. Suzhou Dawnray’s Pharmaceutical Co. Ltd., China


The Government has not received any report regarding certain multinational drug companies have warned Indian generic drug manufacturers to stop supplying drugs meant for treating various chronic diseases.


This was stated by Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha today.

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